10,000 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Shenzhen Vital Signs-KTL Medical Instrument Co Ltd
FDA registration
Shenzhen Vital Signs-KTL Medical Instrument Co Ltd·1 product·🇨🇳 China
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC·Product code DTB·August 12, 2023
ANTI-DS DNA EIA
FDA Adverse Event
Malfunction
·BIO-RAD LABORATORIES DIAGNOSTICS GROUP·Product code KTL·December 16, 2002
Anti-Dna Indirect Immunofluorescent Solid Phase
FDA classification
FDA Class 2
·Anti-Dna Indirect Immunofluorescent Solid Phase
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 31, 2018
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LXH·September 12, 2018
BTL Industries JSC
FDA registration
BTL Industries JSC·13 products·🇧🇬 Bulgaria
ATL TECHNOLOGY LLC
FDA registration
ATL TECHNOLOGY LLC·5 products·🇺🇸 United States
ATL Technology CR Limitada
FDA registration
ATL Technology CR Limitada·16 products·🇨🇷 Costa Rica
ATL Technology DG,Ltd.
FDA registration
ATL Technology DG,Ltd.·14 products·🇨🇳 China
Split Cath® III
FDA UDI
Medical Components, Inc.·00884908004410·14F X 55CM Split Cath® III TRANSLUMBAR KIT (CUF...
LSL HEALTHCARE
FDA UDI
LSL Industries, LLC·00661392009479·ANTI-EMBOLISM STOCKINGS, THIGH LENGTH, SMALL LONG
SPLIT-CATH® III
FDA UDI
Medical Components, Inc.·00884908182286·14F X 40CM Split Cath® III TRANSLUMBAR KIT (CUF...
Split Cath® III
FDA UDI
Medical Components, Inc.·00884908004274·14F X 40CM Split Cath® III TRANSLUMBAR KIT (CUF...
SPLIT-CATH® III
FDA UDI
Medical Components, Inc.·00884908182293·14F X 55CM Split Cath® III TRANSLUMBAR KIT (CUF...
LSL HEALTHCARE
FDA UDI
LSL Industries, LLC·00661392009646·ANTI-EMBOLISM STOCKINGS, THIGH LENGTH, LARGE LONG
LSL HEALTHCARE
FDA UDI
LSL Industries, LLC·00661392009592·ANTI-EMBOLISM STOCKINGS, THIGH LENGTH, MEDIUM LONG
TL,WIRE, BAYONET, 1.8MM X 400MM
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code KTT·March 30, 2016
TL+ METAL DISTRACTION / COMPRESSION NUT
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code LXT·August 8, 2019
TL+ METAL DISTRACTION / COMPRESSION NUT
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code LXT·August 8, 2019